Effects of Pilates in Patients With Post- -COVID-19 Syndrome: Controlled and Randomized Clinical Trial

February 9, 2023 updated by: Michele de Aguiar Zacaria
The COVID-19 is closely related to severe acute respiratory syndrome (SARS) with direct and indirect effects on several systems, especially the musculoskeletal system, in addition to the respiratory system. Some of these symptoms persist for a long time, called Post-COVID-19 Syndrome, directly interfering with the functional capacity and quality of life of these patients. Pilates exercises focus on breathing, postural symmetry, trunk stabilization, flexibility, joint mobility and strengthening through the full range of motion of all joints and not isolated muscle groups. The objective of this study will be to evaluate the clinical and functional effects of a Pilates for patients post hospitalization for COVID-19. A randomized and controlled clinical trial will be conducted, with recruitment patients who have developed the severe form of COVID-19 and required at least 7 days of invasive mechanical ventilation. They will be previously randomized in a 1:1 ratio by electronic system and blindly allocated to the intervention group that will perform an exercise protocol based on the Pilates method, 2x/week, for 12 weeks in therapeutic sessions of identical protocols lasting 60 min. All patients will be evaluated before and after for six minutes walk distance test, peripheral and respiratory muscle strength and endurance, post-COVID-19 functional status, dyspnea, and quality of life. The analysis will be based on intention-to-treat principles. Descriptive statistics will be used to present the characteristics of participants in the two treatment groups. P values less than 0.05 will be considered to indicate statistical evidence of significance. The variables of dyspnea, peripheral and respiratory muscle strength, functional capacity, post-COVID functional status and HRQoL will be analyzed using linear models of repeated measures which included all values measured after randomization with baseline scores and treatment clusters as covariates. Adjusted mean differences will be tested 12 weeks after randomization and start of intervention. Multiple comparisons will be performed using the Tukey Test with p-values adjusted using the Holm procedure. Baseline variables will be evaluated as predictors and moderators of treatment effects, including terms and interaction models. Effect sizes for primary and secondary endpoints will be calculated as Cohen's d from estimated marginal means (SMD) and standard error estimates from the adjusted primary analysis. All analyzes were performed using RStudio version 0.99.486. Results: The expected results are based on the alternative hypothesis that Pilates exercises are clinically effective, improving functional performance, exercise tolerance, reducing symptoms and improving the quality of life of patients with symptoms of Post-COVID-19 Syndrome.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Introduction: COVID-19 is an emerging pandemic disease caused by severe acute respiratory syndrome (SARS-CoV-2). Although most patients infected with SARS-CoV-2 are asymptomatic or have mild symptoms, some patients develop severe symptoms that can long-term impair their quality of life and functional capacity. SARS-CoV-2 is closely related to severe acute respiratory syndrome (SARS) with direct and indirect effects on several systems, especially the musculoskeletal system, in addition to the respiratory system. Some of these symptoms persist for a long time, called Post-COVID-19 Syndrome, directly interfering with the functional capacity and quality of life of these patients. Pilates exercises focus on breathing, postural symmetry, trunk stabilization, flexibility, joint mobility and strengthening through the full range of motion of all joints and not isolated muscle groups. Objectives: The objective of this study will be to evaluate the clinical and functional effects of a Pilates exercise program for patients with Post-Covid-19 syndrome after a period of intensive care admission and invasive mechanical ventilation. Methods: The study will be a clinical, randomized and controlled trial. 48 patients of both sexes, over 18 years of age, who have developed the severe form of COVID-19 and required at least 7 days of invasive mechanical ventilation will be recruited. Patients who currently require supplemental oxygen at home and who present motor, cognitive or neurological alterations that prevent the practice of Pilates will be excluded. They will be previously randomized in a 1:1 ratio by electronic system and blindly allocated to the intervention group that will perform an exercise protocol based on the Pilates method, 2x/week, for 12 weeks in therapeutic sessions of identical protocols lasting 60 min. All patients will be evaluated before and after for six minutes walk distance test, peripheral and respiratory muscle strength and endurance, post-COVID-19 functional status, dyspnea, fatigue and quality of life. The analysis of the data obtained during the research was carried out by an independent statistician who had access to the coded data and were based on intention-to-treat principles. Missing data will be assumed to be completely missing by chance. Multiple imputation was used to explain these missing data (STERNE et al., 2009). Missing values in the outcome variables were estimated using multiple imputation by chained equations after 50 imputed replicated data sets. Variables included in the multiple imputation process included (1) group factor, (2) time factor, and (3) the respective outcome variable. Descriptive statistics will be used to present the characteristics of participants in the two treatment groups. P values less than 0.05 will be considered to indicate statistical evidence of significance. The variables of fatigue, peripheral muscle strength, functional capacity, post-COVID functional status and HRQoL were analyzed using linear models of repeated measures (participants and time as random factors) which included all values measured after randomization with baseline scores and treatment clusters as covariates. Adjusted mean differences will be tested 12 weeks after randomization and start of intervention. Multiple comparisons were performed using the Tukey Test with p-values adjusted using the Holm procedure. Baseline variables were evaluated as predictors and moderators of treatment effects, including terms and interaction models. Effect sizes for primary and secondary endpoints were calculated as Cohen's d from estimated marginal means (SMD) and standard error estimates from the adjusted primary analysis. Effect sizes were interpreted according to Cohen's criteria (small ≤0.2; moderate=0.5; large ≥0.8)(COHEN, 1988). All analyzes were performed using RStudio version 0.99.486. Results: The expected results are based on the alternative hypothesis that Pilates exercises are clinically effective, improving functional performance, exercise tolerance, reducing symptoms and improving the quality of life of patients with symptoms of Post-COVID-19 Syndrome.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
      • Rio De Janeiro, Brazil, 21073-460
        • Recruiting
        • Centro de Fisiatria e Reabilitação da Polícia Militar do Estado do Rio de Janeiro
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients previously diagnosed with COVID-19, who required hospitalization and required invasive mechanical ventilation for at least 7 days and who were discharged between August and December 2021 to minimize regression to mean;
  2. Both sexes;
  3. Over 18 years of age.

Exclusion Criteria:

  1. Need for supplemental home oxygen;
  2. Motor or neurological or cognitive alteration that contraindicates the practice of Pilates.
  3. Persistence of clinical signs of deep vein thrombosis
  4. Upper limb dynamometry < 14 kgs for men and < 7 kgs for women would indicate very marked peripheral muscle weakness and would therefore contraindicate Pliates at the moment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Pilates
The Pilates exercise protocol was designed based on protocols contained in previously published clinical trials whose objective had been muscle strengthening or improvement of muscle fatigue. Thus, the protocol will perform exercises from the classic repertoire of the Pilates Method, using equipment exclusive to the Method - such as Cadillac, Lader Barrel, Chair and Reformer. The sessions will take place twice a week, in a group of up to 3 participants, always in the morning lasting 60 minutes, with 10 minutes of warm-up, 40 minutes of load exercises and 10 minutes of relaxation exercises and calm down. All sessions were carried out by a physiotherapist specialized in the method, in a specific outpatient clinic. The professional who conducted the Pilates sessions, performed the proposed protocol, is unaware of the outcomes studied by the project.
Procedure: Pilates Exercises
The intervention group will perform an exercise protocol based on the Pilates method, by a physiotherapist specialized in Pilates and independent of the researchers, using the method's own equipment, with a frequency of 2x/week, for 12 weeks in therapeutic sessions of identical protocols lasting 60 min.
Other Names:
  • Therapeutic Pilates
NO_INTERVENTION: Control
Only follow-up of the clinical evolution will be carried out

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Functional Capacity
Time Frame: 12 weeks
Functional capacity will be measured by the distance covered in the 6-minute walk test. The distance covered will be expressed in meters and compared in absolute and relative values to predict normality for the studied population.
12 weeks
Functional Status
Time Frame: 12 weeks
Functional status will be measured by the Post-COVID-19 Functional Status scale,which is graded from 0 to 4, with the highest score being the worst.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Peripheral muscle endurance
Time Frame: 12 weeks
The peripheral muscle endurance test will be performed using the constant load test, with the time to exhaustion as the variable of interest.
12 weeks
Respiratory muscle strength
Time Frame: 12 weeks
Respiratory muscle strength will be measured by isometric measurement of maximal respiratory pressures. The maximum respiratory pressures will be measured by a digital manovacuometer, and the measurement used for analysis will be expressed in cmH2O and considered as the highest value sustained for 1s
12 weeks
Peripheral muscle strength
Time Frame: 12 weeks
Peripheral muscle strength will be measured by the manual grip test on the dominant upper limb and by the 1-repetition maximum test (1-RM) for the quadriceps on the same side. The measure used will be expressed in kilograms, as the largest load carried out.
12 weeks
Dyspnea
Time Frame: 12 weeks
Dyspnea will be measured using the modified medical research council scale, graded from 0 to 4, with the highest value being the worst
12 weeks
Health-related quality of life
Time Frame: 12 weeks
Health-related quality of life will be measured by the global score of the short form - 36. This questionnaire is scored from 0 to 100, with the higher the value, the better the health-related quality of life.questionnaire.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Michele de Aguiar Zacaria

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michelle de Aguiar Zacaria, Centro Universitário Augusto Motta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 9, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2023

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2023

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NTC12345678

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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